Meridian Bioscience, Inc. Announces illumigene® Group A Streptococcus and illumigene® Group B Streptococcus Tests Categorized "Moderate Complexity" by FDA
Published: Mar 18, 2013
CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced the U.S. Food & Drug Administration (FDA) has re-categorized Meridian’s illumigene® Group A Streptococcus and illumigene® Group B Streptococcus tests as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be simple and easy to use. The Moderate Complexity categorization of both of these tests allows the benefits of the illumigene platform to be available to all Moderate Complexity laboratories that are in U.S. hospitals and clinics, empowering them to offer an accurate, rapid, simple molecular test for each of these pathogens.